TRENTON
– Attorney General Paula T. Dow announced
today that New Jersey has entered into a
$68.5 million, multi-state settlement agreement
with pharmaceutical manufacturer AstraZeneca
that resolves allegations the company deceptively
marketed its anti-psychotic drug Seroquel.

Under
the settlement agreement, New Jersey will
receive approximately $1.85 million. Thirty-six
states and the District of Columbia also
are party to the settlement, described as
the largest-ever multi-state, consumer-protection-based
pharmaceutical settlement.

A
Verified Complaint, filed in New Jersey
Superior Court today along with a Final
Consent Judgment memorializing the settlement,
charges that AstraZeneca engaged in unfair
and misleading practices when it marketed
Seroquel for unapproved or off-label uses.
The Complaint also alleges that AstraZeneca
failed to adequately disclose the potential
side effects of Seroquel to health care
providers, and withheld negative information
contained in scientific studies regarding
the safety and efficacy of Seroquel.

“This
is an important settlement for all New Jersey
residents,” said Attorney General
Dow. “This case sends a message that
we take seriously the duty pharmaceutical
companies have to supply clear, accurate
and complete information about their products
to health care providers, and to market
their products without deception or misleading
claims.”

“Consumers
rightfully expect pharmaceutical companies
to engage in responsible marketing efforts
that are consistent with approved purposes,”
said Thomas R. Calcagni, Acting Director
of the Division of Consumer Affairs.

“The
importance cannot be overstated, when the
health and safety of New Jersey residents
are at stake,” Calcagni said.

Following a three-year investigation by
the participating states, the Delaware-based
AstraZeneca agreed not to promote Seroquel
in a false, misleading or deceptive manner,
including for “off-label” uses,
which are not approved by the U.S. Food
and Drug Administration. In addition to
the overall $68.5 million payment, terms
of the settlement include provisions that
address specific concerns identified in
the states’ investigation. The agreement
specifically requires AstraZeneca to:

Publicly post its payments to physicians
on a Web site

Have policies in place to ensure that
financial incentives are not given to
marketing and sales personnel for off-label
marketing

Have policies in place to ensure that
AstraZeneca sales personnel do not promote
to health care providers who are unlikely
to prescribe Seroquel for an FDA-approved
use

Cite to Seroquel’s FDA-approved
indications when referencing selected
symptoms, rather than promoting Seroquel
by highlighting symptoms only

Although a physician is allowed to prescribe
drugs for off-label uses, the law prohibits
pharmaceutical manufacturers from marketing
their products for off-label uses. AstraZeneca
allegedly marketed Seroquel for a number
of off-label uses, including for use in
pediatric and geriatric populations, specifically
in nursing homes for Alzheimer’s Disease
and dementia, as well as for anxiety, depression,
sleep disorders, and post traumatic stress
disorder. AstraZeneca promoted Seroquel
for such uses even though Seroquel was not,
at the time it was marketed, approved for
treatment of these conditions, and AstraZeneca
had not established that Seroquel was safe
and effective for these uses. Atypical anti-psychotics,
including Seroquel, can produce dangerous
side effects including weight gain, hyperglycemia,
diabetes, cardiovascular complications and
increased risk of mortality in elderly patients
with dementia.

In addition to New Jersey, the following
states and the District of Columbia participated
in the settlement: Florida, Illinois, Arizona,
California, Colorado, Connecticut, Delaware,
Hawaii, Idaho, Iowa, Kansas, Louisiana,
Maine, Maryland, Massachusetts, Michigan,
Minnesota, Missouri, Nebraska, Nevada, New
Hampshire, New York, North Carolina, North
Dakota, Ohio, Oklahoma, Oregon, Pennsylvania,
Rhode Island, South Dakota, Tennessee, Texas,
Vermont, Washington, West Virginia and Wisconsin.

Money paid to New Jersey as a result of
the AstraZeneca settlement will be used
for consumer protection initiatives. Deputy
Attorney General Gina M. Betts, assigned
to the Division of Law’s Consumer
Fraud Prosecution Section, handled the matter
on behalf of the State.